Use of Corticosteroid in Intraopertive Injections in Total Knee Replacement Surgery.

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
Walter Reed National Military Medical Center
Study ID
NCT07151417
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PAI — DRUG
    Standard PAI: 30 mg Toradol/ketorolac (30mg/ml), 49.25ml 0.5% ropivacaine (5mg/ml), and 0.5 mg
  • PAI + steroid — DRUG
    Standard PAI + 40mg methylprednisolone (n = 40)
  • PAI + zilretta — DRUG
    Standard PAI + 32mg Zilretta (triamcinolone acetonide extended release injectable suspension)

Study Details

The goal of this clinical trial is to find out which type of steroid medicine, when added to a standard pain-control injection during total knee replacement surgery, works best at reducing pain, limiting opioid use, and improving recovery in adults undergoing surgery for severe knee arthritis or injury. The main questions it aims to answer are: Does adding a steroid to the injection improve pain control and reduce opioid use after surgery? Is the newer extended-release steroid (Zilretta) more effective and safer-especially for patients with diabetes-than the traditional steroid (methylprednisolone)? Researchers will compare: Standard pain-control injection alone Standard injection plus methylprednisolone Standard injection plus Zilretta to see which option provides better pain relief, less opioid use, and improved knee function. (Patients with diabetes or prediabetes will only be in the standard injection or Zilretta groups so researchers can study whether Zilretta is safer for blood sugar control.) Participants will: Be randomly assigned to one of the study groups during their total knee replacement surgery Receive the assigned pain-control injection around the knee joint Be followed after surgery to measure: Pain levels Opioid pain medication use Knee movement (range of motion) Whether another procedure (such as manipulation under anesthesia) is needed if the knee becomes too stiff Patient-reported outcome surveys about pain and function

Key Dates

Start date
Sep 1, 2025
Status verified
Aug 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard PAI
    Group1 (n=80; 40 non-diabetic and 40 diabetic participants): Standard PAI: 30 mg Toradol/ketorolac (30mg/ml), 49.25ml 0.5% ropivacaine (5mg/ml), and 0.5 mg epinephrine (1mg/ml), 0.8 ml clonidine (0.1mg/ml) and 8.45 ml 0.9% sodium chloride
  • Active Comparator: Methylprednisolone
    2\. Group2 (n=40, non-diabetic): Standard PAI + 40mg methylprednisolone (n = 40)
  • Active Comparator: Zilretta
    3\. Group3 (n=80; 40 non-diabetic and 40 diabetic participants): Standard PAI + 32mg Zilretta (triamcinolone acetonide extended release injectable suspension)

Primary Outcome Measure

The primary outcome is to determine whether total knee arthroplasty outcomes are significantly better for Zilretta (Group 3) and methylprednisolone (Group 2) as compared to standard PAI (Group 1) and Zilretta versus methylprednisolone. [ Time Frame: 24 hours, 72 hours, 7 days, and 28 days post ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Walter Reed National Military Medical CenterBethesdaMaryland20889
John P Cody, MD
[email protected]
301-538-2472
Garrett Neel, MD (SUB_INVESTIGATOR)
Robert W Tracey, MD (SUB_INVESTIGATOR)
Sean E Slaven, MD (SUB_INVESTIGATOR)
Ian P Marshall, MD (SUB_INVESTIGATOR)
John P. Cody, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Bethesda, MD

By condition
Osteoarthritis (other)
By specialty
OrthopedicsMusculoskeletal disorders
By research site
Walter Reed National Military Medical Center· Bethesda, MD

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